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Risky Cardiovascular Procedures and Known Defective Devices

Posted on in Defective Medical Devices

Heart surgery and the implementation of a heart device are very serious procedures. According to the New York University Langone Medical Center coronary revascularization is one of the most risky heart procedures for patients; however, it is recommended for heart failure patients who have a varying degree of severity of heart problems.

Other types of risky heart procedures include septal myotomy and ventricular restoration. Septal myotomy is conducted to remedy a disease of “unknown origin that causes the heart muscle to thicken,” limiting the heart's ability to pump blood. Ventricular restoration is one of the most common as it is conducted to help restore the functions of a patient's heart after he or she suffers a heart attack.

In addition to these risky surgeries—all which carry a high risk in patient complications—there are a number of heart implant devices that also carry high risk. According to Medscape.com, a recent review of “cardiovascular device approvals in the U.S. suggests only a minority are ever tested against standard treatment” before they are approved for sale in the U.S.

A staggeringly low 40 percent of cardiovascular devices deemed high-risk by the U.S. Food and Drug Administration (FDA) obtained market approval “based on studies that included randomization to 'active comparators.'” Such high-risk devices that received FDA approval, arguably before they had been sufficiently reviewed, include implantable cardioverter-defibrillators, left ventricular assist devices and stents.

Medscape.com notes a slew of other research shows how only 13 percent of “objective performance criteria” are met before many high-risk cardiovascular devices are approved, and 25 percent of performance goals are met. “A full 22 percent of devices obtained FDA approval on the basis of studies with no form of control whatsoever.”

If you or someone you know has experienced negative side effects or serious danger because of a cardiovascular procedure or device that you suspect was not sufficiently vetted, you may be eligible for compensation. The most important fist step is to seek the counsel of a qualified Chicago defective medical device attorney. Contact Newland & Newland, LLP for a free initial consultation today.

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